12 September 2016

Janssen Submits Application Seeking Approval of Sirukumab in European Union for Rheumatoid Arthritis

 Janssen-Cilag International NV (Janssen) announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab forthe treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory condition that affects approximately 6.2 million Europeans.

At Janssen, we are committed to continued innovation in the field of rheumatoid arthritis through new therapeutic options, like sirukumab, that address the medical needs of people living with moderately to severely active rheumatoid arthritis”, said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC. “We look forward to collaborating with the European health authorities with the goal of bringing sirukumab to patients living with rheumatoid arthritis who may benefit from this new biologic therapy.”

Data from the Phase 3 SIRROUND clinical development program, which includes five studies (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M and SIRROUND-LTE), is incorporated into the submission. Results from the SIRROUND-D study were recently presented at the Annual European Congress of Rheumatology (EULAR 2016), and results from the SIRROUND-T and SIRROUND-H studies are planned to be presented later this year.

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